Have Malaria Infections in Kenya Become Less Responsive to Artemisinin Treatment?

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether P. falciparum infections in Kilifi District have developed tolerance to the artemisinin class of drugs.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KEMRI-Wellcome Trust Collaborative Research Program
• Collaborators: Heidelberg University; University of Oxford
• Treatments: Artemisinine; Artemisinins; Artesunate

Criteria

Inclusion Criteria:

• aged between 6 months to 10 years, inclusive

• mono-infection with P. falciparum detected by microscopy;

• parasitaemia of 10,000-300,000/µl asexual forms;

• presence of axillary temperature ≥ 37.5 °C or history of fever during the past 24 h;

• ability to swallow oral medication;

• ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and

• informed consent from a parent or guardian.

Exclusion Criteria:

• presence of clinical danger signs: not able to drink or breast-feed, vomiting (>twice in 24 hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;

• mixed or mono-infection with another Plasmodium species detected by microscopy;

• presence of severe acute malnutrition defined as weight for height <70% of the median NCHS/WHO (Appendix 2);

• presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);

• regular medication, which may interfere with antimalarial pharmacokinetics or pharmacodynamic assessments (e.g., antibiotics with known antimalarial activity); and

• history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).